Immobilization in External Rotation After First Time Anterior Shoulder Dislocation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00707018
First received: June 26, 2008
Last updated: December 11, 2013
Last verified: January 2013

June 26, 2008
December 11, 2013
September 2004
February 2012   (final data collection date for primary outcome measure)
Recurrent instability consisting of a documented episode of anterior shoulder dislocation or multiple episodes of shoulder subluxation. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00707018 on ClinicalTrials.gov Archive Site
  • Patient self reported outcome measures [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Time to return to work or sport [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Immobilization in External Rotation After First Time Anterior Shoulder Dislocation
Immobilization in External Rotation After First Time Anterior Shoulder Dislocation: A Prospective Randomized Study

Comparison of immobilization in internal versus external rotation after first time anterior shoulder dislocation.

The purpose of this study is to compare immobilization in internal versus external rotation after first time anterior shoulder dislocation, and thereby increase our knowledge about the best standard of care.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Shoulder Dislocation
  • Device: External rotation shoulder sling
    The external rotation sling will be adjusted to position the injured upper extremity in 90 degrees of elbow flexion, 0 degrees of shoulder abduction and flexion, and 10 to 15 degrees of external rotation at the shoulder.
  • Device: Internal rotation shoulder sling
    The internal rotation sling will be adjusted to position the injured upper extremity in 90 degrees of elbow flexion, 0 degrees of shoulder abduction and flexion, and 70 to 80 degrees of internal rotation at the shoulder.
  • Experimental: External rotation shoulder sling
    External rotation shoulder sling
    Intervention: Device: External rotation shoulder sling
  • Active Comparator: Internal rotation shoulder sling
    Internal rotation shoulder sling
    Intervention: Device: Internal rotation shoulder sling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
February 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 14 to 30 years of age
  • Willing to participate in follow-up for at least two years
  • Acute, first-time, traumatic, isolated anterior dislocation of the shoulder

Exclusion Criteria:

  • Previous instability of the affected shoulder
  • A history of significant ligamentous laxity or demonstrated multi-directional instability of the opposite shoulder
  • Inability or unwillingness to comply with sling immobilization, rehabilitative protocol, or required follow-up assessments
  • Incompetent or unwilling to consent
  • A medical condition making the patient unable to wear a sling
  • Significant associated fracture (Exception Hill Sachs of >20% or bony Bankart lesions>10%)
  • Neurovascular compromise of the affected limb
  • Concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program.
Both
14 Years to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00707018
04-0088
No
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Eric C McCarty, MD University of Colorado, Denver
University of Colorado, Denver
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP